Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism

Condition(s) targeted: Male Hypogonadism

Intervention: Oral testosterone undecanoate, LPCN 1021 (Drug); Topical testosterone gel 1.62 % (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Lipocine Inc.

Official(s) and/or principal investigator(s):
Anthony DelConte, MD, Study Director, Affiliation: Chief Medical Director, Lipocine, Inc.

The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.

Official title: Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of LPCN 1021-treated subjects who achieve a total testosterone concentration [Cavg] between 300 - 1140 ng/dL.

Secondary outcome:

Percentage of LPCN 1021-treated subjects with maximum serum T concentrations (Cmax) values that are (a) less than 1500 ng/dL; (b) between 1800 and 2500 ng/dL, and (c) greater than 2500 ng/dL

Change from baseline in patient reported outcomes for LPCN 1021 (i.e., International Prostate Symptom Score [I-PSS], Psychosexual Daily Questionnaire [PDQ], Short Form-36 Questionnaire [SF-36])

Change from baseline to 52 weeks in safety laboratory parameters (i.e., clinical chemistry, hematology, PSA)

Number of subjects with adverse events during 52 weeks of treatment

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Male.

Criteria:

Inclusion Criteria: 1. Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired). 2. Serum total testosterone < 300 ng/dL based on 2 consecutive blood samples Exclusion Criteria: A subject will not be eligible for study participation if he meets any of the following criteria. 1. History of significant sensitivity or allergy to androgens, castor oil or product excipients. 2. Clinically significant findings in the prestudy examinations. 3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or I-PSS score > 19 points. 4. Body mass index (BMI) ≥ 38 kg/m2. 5. Clinically significant abnormal laboratory values 6. Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus antibodies (HIV Ab). 7. History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures. 8. History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption. 9. History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study drug administration. 10. History of stroke or myocardial infarction within the past 5 years. 11. History of, or current or suspected, prostate or breast cancer. 12. History of diagnosed, severe, untreated, obstructive sleep apnea. 13. History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years. 14. History of long QT syndrome or unexplained sudden death in a first degree relative (parent, sibling, or child). 15. Concurrent treatment with medications which may impact the absorption, distribution, metabolism or excretion of testosterone undecanoate (TU) or place the subject at risk for treatment with testosterone. 16. Subject has a partner who is currently pregnant or planning pregnancy during the course of the clinical trial.

Starting date: February 2014
Last updated: July 10, 2015